(TheStreet) May 17, 2017 - Attention cancer immunotherapy followers: The ASCO "IDO" party has kicked off. Never-before-seen data from mid-stage clinical trials combining Incyte's IDO inhibitor epacadostat with Keytruda and Opdivo, the anti-PD-1 checkpoint inhibitors marketed by Merck and Bristol-Myers Squibb, respectively, have been released tonight.

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H. Jack West, MD (Posted: May 18, 2017)

In the feeding frenzy that is the business world's hype-driven interpretation of immunotherapy data, the point that the response rate in phase II trials is typically significantly higher than the better established phase III trial data is conveniently overlooked. Could IDO combinations represent a significant improvement? Sure. But docetaxel had a 25% response rate in progressing phase II trials, and carbo/taxol had a 50% response rate as first line treatment in early phase II work, and we all marvel at those crazy numbers when we learn the more sobering reality from far larger clinical trials and greater experience. This kind of breathless over-reaction to early studies is like a Darwin award of investment. Good luck, guys. Just remember that I told you not to jump off the cliff together, like a sea of lemmings. It's the same reflexive rather than conscious thought-driven process.

(AstraZeneca) May 12, 2017 - Imfinzi met a primary endpoint of statistically-significant and clinically-meaningful progression-free survival (PFS) in ‘all-comer’ patients with locally-advanced, unresectable (Stage III) non-small cell lung cancer in a planned interim analysis; Imfinzi is the first immuno-oncology medicine to show superior PFS in this setting; plans for regulatory submission under active discussion with authorities.

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H. Jack West, MD (Posted: May 12, 2017)

Though it will be far more important to see this difference translate to a significant improvement in overall survival, this early result based on an interim report is very encouraging and has great potential to finally improve on our longstanding standard of concurrent chemo/radiation in patients with locally advanced NSCLC. Along with needing to clarify whether there is an overall survival advantage, we will need to clarify whether the benefits of durvalumab are seen comparably in patients with squamous and non-squamous NSCLC and across different levels of PD-L1 expression. These results will be among the most anticipated in lung cancer over the next several months.

(Merck) May 10, 2017 - Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, in combination with pemetrexed (brand name Alimta®) and carboplatin (pem/carbo), a commonly used chemotherapy regimen, for the first-line treatment of metastatic nonsquamous NSCLC, irrespective of PD-L1 expression.

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H. Jack West, MD (Posted: May 10, 2017)

This is a weak approval based on disappointingly scant evidence, especially considering that 37 of 123 patients (30%) enrolled had 50% or greater PD-L1 expression and would now be considered as having pembrolizumab monotherapy as standard of care. With the phase III KEYNOTE-189 with the same trial design but larger, and already completed (as well as many other trials of chemo +/- checkpoint inhibitor therapy), it is disappointing that we saw such a rush to judgment. It should be viewed as putting marketing ahead of true evidence. Perhaps the more mature overall survival data (not highlighted in the press release) are more compelling now than at the time of the initial presentation and publication in October, 2016. Unfortunately, I'm afraid we will soon see that the FDA functions merely to rubber stamp marketing efforts with the slightest pretense of evidence to support commercial interests, rather than to offer a critical review of the true value of unfathomably expensive treatments that provide technically positive results on watered down endpoints.